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Completed

NCT Number: NCT02595463

Intravenous Lidocaine for Post-Tonsillectomy Pain in Pediatric Patients

The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain.

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Key information

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, 60611, United States

About this study

The purpose of this study is to determine whether giving lidocaine intravenously during and after a tonsillectomy surgery is effective in decreasing postoperative pain when compared to placebo.

Participants will be in one of two arms. Those in Arm 1 will receive a lidocaine bolus and infusion throughout the initial recovery period while those in Arm 2 will receive an equal volume of normal saline. Subjects will be monitored and assessed for pain during their time in the hospital and followed up on at home for a week after the surgery. Primary outcomes will be measure of pain. Secondary outcome measures will include pain medication use, emergence delirium, incidence of laryngospasm, and side effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for Tonsillectomy (with or without Adenoidectomy) with Dr. Kathleen Billings or Dr. Stephen Hoff at Lurie Children's Hospital
  • American Society of Anesthesiology (ASA) patient classification I-III (Healthy patient to a patient with mild systemic disease)

Exclusion criteria

  • Physical or developmental delays
  • Psychiatric illness
  • Current use of sedative or anticonvulsant medications
  • Pre-existing renal disease (ranging from stage 2 [mild] to stage 5 [end stage])
  • Pre-existing cardiovascular disease (including, not limited to congenital heart disease or arrythmia)
  • Pre-existing liver disease
  • Pre-existing cerebral or neuromuscular disease
  • Patient or family history of Malignant Hyperthermia
  • Recent history of upper respiratory infection within last 7 days
  • Regular use of analgesic medication
  • Diagnosis of severe obstructive sleep apnea requiring overnight stay for observation
  • Other procedure scheduled in addition to tonsillectomy
  • History of allergies to local anesthetics

Treatment and study plan

Lidocaine

Drug

Intraoperative dose of intravenous lidocaine followed by an infusion until discharge from the initial recovery period.

Other names: Xylocaine, Lidocaine Hydrochloride

Saline

Drug

Intraoperative dose of saline followed by an infusion until discharge from the initial recovery period.

Other names: Placebo

Primary outcomes

  1. Observer Rated Pain Intensity

    Time frame: Within the immediate post-operative period (90 minutes after surgery)

    Observer Rated Pain Intensity will be measured using the Children's Eastern Ontario Pain Scale (CHEOPS) at regular 5 and 15 minute time intervals.

Secondary outcomes

  1. Patient Rated Pain Intensity

    Time frame: Within the immediate post-operative period (90 minutes after surgery)

    Patient Rated Pain Intensity will be measured using the Faces Pain Scale - Revised (FPS-R) by pointing to pictures of faces displaying a spectrum of pain at regular 5 and 15 minute time intervals.

  2. Observer Rated Emergence Delirium

    Time frame: Within the immediate post-operative period (90 minutes after surgery)

    Observer Rated Emergence Delirium will be measured using the he Pediatric Emergence Delirium (PAED) Scale at regular 5 and 15 minute time intervals.

  3. Observer Rated PACU Discharge Criteria

    Time frame: Within the immediate post-operative period (90 minutes after surgery)

    Observer Rated PACU Discharge Criteria will be measured using the modified Aldrete Scale at regular time intervals.

  4. Parent Rated Postoperative Pain at Home

    Time frame: Every day, up to 7 days postoperatively

    Parent Rated Postoperative Pain at Home will be measured using the Parents Postoperative Pain Measures (PPPM) questionnaire and Numerical Rating Scale to report on the intensity of their child's pain.

  5. Medication Journal

    Time frame: Every day, up to 7 days postoperatively

    Parents will keep a journal of all pain medication given to their children to treat pain.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

Intravenous Lidocaine to Decrease Postoperative Pain in Pediatric Patients Undergoing Tonsillectomy: A Randomized, Double Blind, Placebo Controlled Trial

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Nov 3, 2015
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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